Department of Medical Sciences, IRCCS San Raffaele Roma, Rome, Italy.
Int J Cardiol. 2011 Sep 1;151(2):218-24. doi: 10.1016/j.ijcard.2011.06.098. Epub 2011 Jul 18.
Patients with heart failure (HF) have reduced exercise capacity. The beneficial effect of beta-blocker on prognosis is not matched by an impact on exercise capacity and quality of life. We performed a randomised open blinded endpoint study to assess the effect of heart rate reduction with carvedilol, ivabradine, and their combination on exercise capacity in HF patients receiving maximal dose of ACE inhibitor.
After a run-in phase patients were randomly allocated to 3 groups: carvedilol up to 25mg bid (n=38); ivabradine up to 7.5mg bid (n=41); and carvedilol/ivabradine up to 12.5/7.5mg bid (n=42). The maximal dose of study treatment was more frequently tolerated in patients receiving ivabradine (36/41) than in those receiving carvedilol (18/38) or combination therapy (32/42) (P<0.01 ivabradine versus carvedilol). Heart rate was reduced in all three groups, but to a greater extent by the combination. The distance walked on the 6-min walking test and the exercise time on MVO(2) test significantly improved in the ivabradine and combination groups (both P<0.01 versus baseline), as did peak VO(2) and VAT (P<0.01 for ivabradine and P<0.03 for combination versus carvedilol, respectively). No changes in these parameters were found with carvedilol. The patients receiving ivabradine or the combination had better quality of life (P<0.01 versus baseline for ivabradine and P<0.02 for combination), versus no change with carvedilol.
Ivabradine alone or in combination with carvedilol is more effective than carvedilol alone at improving exercise tolerance and quality of life in HF patients.
心力衰竭（HF）患者的运动能力降低。β受体阻滞剂对预后的有益影响并未转化为运动能力和生活质量的改善。我们进行了一项随机、开放、盲终点研究，以评估在接受最大剂量 ACE 抑制剂治疗的 HF 患者中，通过降低心率来使用卡维地洛、伊伐布雷定及其组合对运动能力的影响。
在导入期后，患者被随机分配至 3 组：卡维地洛（bid）25mg 组（n=38）；伊伐布雷定（bid）7.5mg 组（n=41）；卡维地洛/伊伐布雷定（bid）12.5/7.5mg 组（n=42）。接受伊伐布雷定治疗的患者（36/41）更能耐受研究治疗的最大剂量，而接受卡维地洛（18/38）或联合治疗（32/42）的患者则不能（伊伐布雷定与卡维地洛比较，P<0.01）。三组患者的心率均降低，但联合组降低幅度更大。6 分钟步行试验的步行距离和 MVO(2)试验的运动时间在伊伐布雷定和联合组均显著改善（均 P<0.01 与基线相比），峰值 VO(2)和 VAT 也改善（伊伐布雷定与卡维地洛比较，P<0.01；联合与卡维地洛比较，P<0.03）。卡维地洛组则无这些参数的变化。接受伊伐布雷定或联合治疗的患者生活质量更好（伊伐布雷定与基线比较，P<0.01；联合与卡维地洛比较，P<0.02），而卡维地洛组则无变化。
伊伐布雷定单独或与卡维地洛联合使用比单独使用卡维地洛更能有效改善 HF 患者的运动耐量和生活质量。
